SR PROJECT ENGINEER

Job Summary

This position will manage implementation of projects related to the manufacturing of terminal sterilized pharmaceutical bags. Will ensure inclusion of existing site operation, facility and engineering team members in the learning and design process for those new systems.
This position is responsible for providing process analysis, actively seeks and executes process improvement ideas and manages process improvement projects designed to increase or improve productivity, capacity, or safety.
The responsibilities also include operations support liaison with Technology, providing support to operations, technology transfer and quality teams while escalating when required.Responsibilities

• Manage and supervise the installation of equipment and/or facility modifications or additions to include selecting and coordinating suppliers, procuring equipment and services, scheduling, rigging, set-up, start-up, troubleshooting, de-bugging, training and budgeting.
• Develop and manage site projects by employing experience, research, design and concept sketches, layouts, drawings, supplier interaction, preparation of specifications, and discussions with appropriate management and site personnel.
• Understand the overall process sequences beyond individual equipment and impact on product quality.
• Analyze production and processing issues and initiate activities to resolve them.
• Develop product and process knowledge in process areas.
• Prepare and maintain process technical investigative reports for knowledge management.
• Identify, promote, and support the operation team on tasks/projects to improve product quality and yield.
• Design evaluation studies/ analysis of manufacturing equipment and systems, collect data, interpretation and report writing with supervisor guidance.
• Identify variances to assist in developing strategies to improve process performance and reduce cost.
• Promote strategies for efficiency improvements to operations.
• Support implementation of organization process improvement initiatives and evaluate results.
• Investigate deviations from standards of manufacturing process using effective root cause analysis tools. Recommend effective corrective and preventative actions to operations team and support the implementation if required.
• Understanding of Critical Process Parameters (CPPs) and other process conditions needed to reliably manufacture product which consistently meets its Critical Quality Attributes (CQAs).
• Participate in risk assessments and validation activities.
• Maintains the interfaces with support functions (i.e., QA, QC, Engineering Services) and the production function to ensure availability of equipment and continuous improvement of the process.
• Assist with fundamental operation/equipment functionality training as appropriate.
• Set up and maintain process instruction for training and troubleshooting purposes.
• All employees are responsible for ensuring the compliance to company documents, programs and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities

Requirements:

• Must have a bachelor’s degree in Engineering.
• Must have at least 3-years manufacturing experience in a cGMP environment.
• Must have at least 3-years hands on experience with validated manufacturing process systems.
• Desirable to have Project Management experience in a food, pharmaceutical or regulated environment.
• Must be able to generate reports, deviations, or other technical documents.
• Must be PC literate with standard office applications (Word, Excel, PowerPoint, Project, Access) competency.
• Must have Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques.
• Must have understanding of statistical analysis tools and methods.
• Desirable to have knowledge of cGMP Process and Product Validation requirements and techniques.
• Desirable to have knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques.
• Experience in Automated Batch, Continuous Process and Formulation systems is preferred.
• Experience in pharmaceutical instrumentation is preferred.
• Desirable to have experience with critical utilities (WFI, OFCA, Clean Steam, HVAC).
• Desirable to have CIP/SIP experience.
• Desirable to have Clean Room experience.
• Desirable to have Process Control and instrumentation experience.
• Desirable to have experience in Decontamination process in aseptic manufacturing.
• Knowledge of Clean Room Classifications is a plus.

Additional Information

We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.

Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.